Lesinurad

(Bempedoic acid)

ApprovedSmall molecule

Bempedoic acid is used to lower uric acid levels in the blood to help prevent gout attacks, which cause sudden painful swelling in joints.[2] Lesinurad is currently approved and in use across 13 indications[4].[1]

Lesinurad is one of 269 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

268

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Disorder of Lipid MetabolismApproved

Cardiovascular DiseaseActive, not recruiting

HyperlipidemiaActive, not recruiting

Abnormal Circulating Lipid ConcentrationActive, not recruiting

Alcoholic Fatty Liver DiseaseActive, not recruiting

Type 2 Diabetes MellitusRecruiting

Familial HypercholesterolemiaActive, not recruiting

AtherosclerosisActive, not recruiting

Polycystic Kidney DiseaseActive, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Disorder of Lipid MetabolismApproved

Approved

Cardiovascular DiseasePhase 3

Active, not recruiting

HyperlipidemiaPhase 3

Active, not recruiting

Abnormal Circulating Lipid ConcentrationApproved

Active, not recruiting

Alcoholic Fatty Liver DiseasePreclinical

Active, not recruiting

Type 2 Diabetes MellitusApproved

Recruiting

Familial HypercholesterolemiaPhase 2

Active, not recruiting

AtherosclerosisApproved

Active, not recruiting

Polycystic Kidney DiseasePhase 2

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

676 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

Lesinurad

EEsperion Therapeutics, Inc.

Approved

1 2

Tanzeum

GSK

Preclinical

10 3

Insulin 320

Novo Nordisk

Preclinical

43 4

NOVOLIN R

Novo Nordisk

Preclinical

1 5

Adenocard

Astellas

Preclinical

1 6

Dostinex

Cipro

Myrbetriq

Lantus

6 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Not yet recruiting

Prevention

NCT07239414

Q1 2028

Recruiting

Primary

NCT06686615

Phase 2Recruiting

Inflammation

NCT05488431

Q4 2028

Phase 3Not yet recruiting

Cardiovascular Events

NCT07474649

Recruiting

Treatment

NCT07374861

Q3 2029

Phase 2Not yet recruiting

Polycystic Kidney Disease

NCT07282821

Clinical

Trials by Indication[1]

Hypercholesterolemia3 trials

SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI®

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT05546398·500 enrolled

A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT06450366·301 enrolled

A Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT06925100·180 enrolled

Efficacy and Safety3 trials

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03001076·269 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT03193047·59 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT03051100·63 enrolled

Safety and Efficacy2 trials

Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03067441·1,462 enrolled

A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03337308·382 enrolled

Atorvastatin2 trials

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07268625·58 enrolled

A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07235189·58 enrolled

Statin2 trials

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07182383·58 enrolled

Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07201545·58 enrolled

16 more indications

Hyperlipidemia2 trials

Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT02991118·779 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT02988115·345 enrolled

Efficacy2 trials

A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06742853·81 enrolled

A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid

Recruiting·GGan & Lee Pharmaceuticals.·Phase 3·NCT06780410·240 enrolled

Cardiovascular Events1 trial

A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

Not yet recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT07474649·103 enrolled

Pregnancy1 trial

Bempedoic Acid Pregnancy Surveillance Program

Recruiting·EEsperion Therapeutics, Inc.··NCT05103254·20 enrolled

Familial Hypercholesterolemia1 trial

A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT05694260·31 enrolled

Alcoholic Fatty Liver Disease1 trial

Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes

Recruiting·MMedanta, The Medicity, India·N/A·NCT06035874·100 enrolled

Treatment1 trial

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy

Recruiting·FFederico II University··NCT07374861·1,500 enrolled

Inflammation1 trial

Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)

Recruiting·PPriscilla Hsue, MD·Phase 2·NCT05488431·121 enrolled

Concentration1 trial

Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women

Completed·EEsperion Therapeutics, Inc.·Phase 4·NCT06021951·16 enrolled

Polycystic Kidney Disease1 trial

Bempedoic Acid Therapy for Polycystic Kidney Disease

Not yet recruiting·KKenneth Hallows·Phase 2·NCT07282821·120 enrolled

Fasting Conditions1 trial

Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06923956·14 enrolled

Cardiovascular Disease1 trial

Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT02993406·13,970 enrolled

Prevention1 trial

Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability

Not yet recruiting·SSohaib Ashraf·Phase 3·NCT07239414·690 enrolled

OIC1 trial

Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT07170852·32 enrolled

Primary1 trial

Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo··NCT06686615·2,000 enrolled

Type 2 Diabetes Mellitus1 trial

Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin/Ezetimibe, Bempedoic Acid/Ezetimibe, and Rosuvastatin/Ezetimibe/Bempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol

Recruiting·BBahria University·Approved·NCT07255820·126 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 21, 2020

NEXLETOL

NDA NDA211616

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Bempedoic acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lesinurad drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bempedoic acid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bempedoic acid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211616). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lesinurad. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Esperion Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: ATP-Citrate Synthase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EEsperion Therapeutics, Inc.

Patent Landscape[6]

Patent Cliff

Mar 14, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11744816Mar 14, 2036

12398087Jun 19, 2040

Lesinurad

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Q4 2028

Q3 2029

Trials by Indication[1]

Hypercholesterolemia3 trials

Efficacy and Safety3 trials

Safety and Efficacy2 trials

Atorvastatin2 trials

Statin2 trials

Hyperlipidemia2 trials

Efficacy2 trials

Cardiovascular Events1 trial

Pregnancy1 trial

Familial Hypercholesterolemia1 trial

Alcoholic Fatty Liver Disease1 trial

Treatment1 trial

Inflammation1 trial

Concentration1 trial

Polycystic Kidney Disease1 trial

Fasting Conditions1 trial

Cardiovascular Disease1 trial

Prevention1 trial

OIC1 trial

Primary1 trial

Type 2 Diabetes Mellitus1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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